Eligibility Hypertension NCT02499822

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
male and female subjects
boolean
C0079399 (UMLS CUI [1])
Age
Item
age 35-75 years
boolean
C0001779 (UMLS CUI [1])
Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy Absent
Item
clinic systolic bp ≥140 mmhg and/or diastolic bp ≥ 90 mmhg (under no antihypertensive treatment)
boolean
C0871470 (UMLS CUI [1])
C0428883 (UMLS CUI [2])
C0585941 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Ambulatory Blood Pressure Monitoring Daytime | Systolic Pressure | Diastolic blood pressure | Antihypertensive therapy Absent
Item
daytime bp on ambulatory bp monitoring (abpm) ≥135 mmhg systolic and/or ≥85 mmhg diastolic (under no antihypertensive treatment)
boolean
C0242876 (UMLS CUI [1,1])
C0332169 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0585941 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Systolic Pressure Standard deviation | Ambulatory Blood Pressure Monitoring Systolic Pressure Standard deviation
Item
home sbp standard deviation (sd) >7 mmhg and/or daytime ambulatory sbp sd >12 mmhg
boolean
C0871470 (UMLS CUI [1,1])
C0871420 (UMLS CUI [1,2])
C0242876 (UMLS CUI [2,1])
C0871470 (UMLS CUI [2,2])
C0871420 (UMLS CUI [2,3])
Patients Untreated | Antihypertensive Agents Quantity | Antihypertensive Agents Low dose Quantity | Status post Washout Period
Item
patients may be included if untreated or, if treated with one antihypertensive drug or two drugs in low doses, after 2 weeks' washout period
boolean
C0030705 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C0003364 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0003364 (UMLS CUI [3,1])
C0445550 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
C0231290 (UMLS CUI [4,1])
C1710661 (UMLS CUI [4,2])
Informed Consent
Item
written informed consent to participate in the study
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Antihypertensive Agents Quantity | Exception Antihypertensive Agents Quantity Low dose
Item
subjects treated with ≥ 2 antihypertensive drugs (except those on two drugs in low doses)
boolean
C0003364 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0003364 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0445550 (UMLS CUI [2,4])
Study Subject Treated | Systolic Pressure | Diastolic blood pressure
Item
treated subjects with on-treatment clinic bp ≥160 mmhg systolic and/or 100 mmhg diastolic
boolean
C0681850 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Antihypertensive therapy Discontinuation Unacceptable
Item
treated antihypertensive subjects in whom withdrawal of treatment is deemed unethical by the investigator (e.g. because of the existence of compelling indications other than hypertension for continuous use of previously used antihypertensive agent)
boolean
C0585941 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1883420 (UMLS CUI [1,3])
Medical contraindication Investigational Therapy | Ramipril allergy | Hypersensitivity Ramipril Excipient | Angiotensin-converting-enzyme inhibitor allergy | Angioedema | Therapeutic procedure Extracorporeal At risk | Bilateral renal artery stenosis | Renal Artery Stenosis Kidney Functioning Solitary | Pregnancy Second Trimester | Pregnancy Third Trimester | Breast Feeding | Renal Artery Stenosis | Patients Hypotensive | Hemodynamic instability | Other Coding | Nifedipine allergy | Hypersensitivity Nifedipine Excipient | Shock, Cardiogenic | Rifampin | Kock Pouch
Item
contraindications to study treatments as detailed in the relative summaries of medical product characteristics for ramipril (hypersensitivity to ramipril or any of the excipients or any other ace inhibitor, history of angioneurotic oedema, extracorporeal treatments leading to contact of blood with negatively charged surfaces, significant bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney, second and third trimesters of pregnancy, lactation, haemodynamically relevant renal artery stenosis, hypotensive or haemodynamically unstable patients) or nifedipine gits (known hypersensitivity to nifedipine or to any of the excipients, pregnancy before week 20 and during breastfeeding, cardiovascular shock, concomitant treatment with rifampicin, patients with a kock pouch)
boolean
C1301624 (UMLS CUI [1,1])
C0949266 (UMLS CUI [1,2])
C0571943 (UMLS CUI [2])
C0020517 (UMLS CUI [3,1])
C0072973 (UMLS CUI [3,2])
C0015237 (UMLS CUI [3,3])
C0571939 (UMLS CUI [4])
C0002994 (UMLS CUI [5])
C0087111 (UMLS CUI [6,1])
C0442087 (UMLS CUI [6,2])
C1444641 (UMLS CUI [6,3])
C0856760 (UMLS CUI [7])
C0035067 (UMLS CUI [8,1])
C0022646 (UMLS CUI [8,2])
C0542341 (UMLS CUI [8,3])
C0205171 (UMLS CUI [8,4])
C0032980 (UMLS CUI [9])
C0032981 (UMLS CUI [10])
C0006147 (UMLS CUI [11])
C0035067 (UMLS CUI [12])
C0030705 (UMLS CUI [13,1])
C0857353 (UMLS CUI [13,2])
C0948268 (UMLS CUI [14])
C3846158 (UMLS CUI [15])
C0570915 (UMLS CUI [16])
C0020517 (UMLS CUI [17,1])
C0028066 (UMLS CUI [17,2])
C0015237 (UMLS CUI [17,3])
C0036980 (UMLS CUI [18])
C0035608 (UMLS CUI [19])
C0086512 (UMLS CUI [20])
Cardiovascular Diseases | Exception Hypertensive disease | Coronary heart disease | Heart failure | Left ventricular systolic dysfunction Degree Any | Atrial Fibrillation | Cardiac Arrhythmia Frequent | Heart valve disease | Congenital heart disease | Cardiomyopathy | Cerebrovascular Disorders | Peripheral Arterial Diseases | Aortic Aneurysm
Item
cardiovascular diseases other than hypertension (coronary heart disease, heart failure or left ventricular systolic dysfunction of any degree, atrial fibrillation or frequent arrhythmias, valvular or congenital heart disease, cardiomyopathies, cerebrovascular disease, peripheral artery disease, aortic aneurysm)
boolean
C0007222 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0020538 (UMLS CUI [2,2])
C0010068 (UMLS CUI [3])
C0018801 (UMLS CUI [4])
C1277187 (UMLS CUI [5,1])
C0441889 (UMLS CUI [5,2])
C1552551 (UMLS CUI [5,3])
C0004238 (UMLS CUI [6])
C0003811 (UMLS CUI [7,1])
C0332183 (UMLS CUI [7,2])
C0018824 (UMLS CUI [8])
C0152021 (UMLS CUI [9])
C0878544 (UMLS CUI [10])
C0007820 (UMLS CUI [11])
C1704436 (UMLS CUI [12])
C0003486 (UMLS CUI [13])
Chronic Kidney Disease
Item
chronic kidney disease
boolean
C1561643 (UMLS CUI [1])
Secondary hypertension Suspected | Secondary hypertension
Item
suspected or confirmed secondary hypertension
boolean
C0155616 (UMLS CUI [1,1])
C0750491 (UMLS CUI [1,2])
C0155616 (UMLS CUI [2])
Diabetes Mellitus
Item
diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Indication Antihypertensive Agents Specific
Item
subjects with conditions other than those mentioned above, where compelling indications for the use of any specific class of antihypertensive medication exist, according to current (e.g. european society of cardiology) guidelines
boolean
C3146298 (UMLS CUI [1,1])
C0003364 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Other medical condition Relevant | Respiration Disorders | Liver diseases | Kidney Diseases | Thyroid Diseases
Item
other conditions deemed relevant by the investigator (including respiratory disorders, liver disease, renal disease, thyroid disorders)
boolean
C3843040 (UMLS CUI [1,1])
C2347946 (UMLS CUI [1,2])
C0035204 (UMLS CUI [2])
C0023895 (UMLS CUI [3])
C0022658 (UMLS CUI [4])
C0040128 (UMLS CUI [5])
Body mass index
Item
bmi ≥35 kg/m2
boolean
C1305855 (UMLS CUI [1])
Obstructive Sleep Apnea Severe | Apnea-hypopnea index | Continuous Positive Airway Pressure
Item
known severe obstructive sleep apnea (apnea-hypopnea index > 30 or use of cpap)
boolean
C0520679 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C2111846 (UMLS CUI [2])
C0199451 (UMLS CUI [3])
Premenopausal state Contraceptive methods Absent
Item
premenopausal women not using effective contraceptive methods
boolean
C0232969 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
Protocol Compliance Unlikely
Item
elevated probability of noncompliance with the study procedures
boolean
C0525058 (UMLS CUI [1,1])
C0750558 (UMLS CUI [1,2])
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